Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.Ībsorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. A higher incidence has been seen in patients treated concurrently with cimetidine. The incidence of leucopenia in various reports averages about 20%. Recovery is not influenced by continuation of silver sulfadiazine therapy. Rebound to normal leukocyte levels follows onset within two to three days. Maximal white blood cell depression occurs within two to four days of initiation of therapy. Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy. Pediatric Use Safety and effectiveness in children have not been established. Because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. However, sulfonamides are known to be excreted in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus. Nursing Mothers It is not known whether Thermazene Cream is excreted in human milk. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. There are, however, no adequate and well-controlled studies in pregnant women. Pregnancy Category B A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in Thermazene Cream and has revealed no evidence of harm to the fetus due to silver sulfadiazine. Long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in Thermazene (Silver Sulfadiazine) Cream, 1% revealed no evidence of carcinogenicity. Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.Ĭarcinogenesis, Mutagenesis, Impairment of Fertility Genus and Species 50 micrograms/mL 100 micrograms/mL Results of in Vitro Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains / Total Number of Strains Tested Silver sulfadiazine acts only on the cell wall to produce its bactericidal effect. Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine. Results from in vitro testing are listed below. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. Silver sulfadiazine has broad antimicrobial activity.
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